DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendments
1) Acknowledgment is made of Applicants’ preliminary amendments filed 07/24/25 and 07/13/2023.
Election
2) Acknowledgment is made of Applicants’ election filed 07/24/2025 in response to the restriction and the species election requirement mailed 05/29/2025. Applicants have elected, with traverse, invention I, and the SEQ ID NO: 35 serpin peptide species, the dermatitis and atopic dermatitis disease or condition species, and the topical administration species. Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse. M.P.E.P § 818.03(a).
Status of Claims
3) Claims 1, 8, 10-13, 22, 23, 26, 27, 61, 75, 76, 93, 109 and 110 have been amended via the preliminary amendment filed 07/13/23.
Claims 2-7, 9, 14-21, 24, 25, 28-60, 62-71, 77-92, 94-103, 105-108 and 111-128 have been canceled via the preliminary amendment filed 07/13/23.
Claim 1 has been amended via the preliminary amendment filed 07/24/25.
Claims 1, 8, 10-13, 22, 23, 26, 27, 61, 72-76, 93, 104, 109 and 110 are pending.
The examination has been extended to oral and parenteral administration species.
Claims 12, 22, 27, 61, 72-76, 93, 104 and 109 are withdrawn from consideration as being directed to a non-elected invention or species. See 37 CFR 1.142(b) and M.P.E.P § 821.03.
Claims 1, 8, 10, 11, 13, 23, 26 and 110 are under examination.
Information Disclosure Statement
4) Acknowledgment is made of Applicants’ Information Disclosure Statement filed 05/05/25. The information referred to therein has been considered and a signed copy is attached to this Office Action.
Sequence Listing
5) Acknowledgment is made of Applicants’ sequence listing which has been entered on 07/21/23.
Drawings
6) Acknowledgment is made of Applicants’ replacement drawings filed 07/13/23 and the drawings filed 12/30/2022.
Substitute Specification
7) Acknowledgment is made of Applicants’ substitute specification filed 07/13/23.
Priority
8) The instant AIA application, filed 12/30/2022, claims priority to the provisional application 63/266,444 filed 01/05/2022.
Objection(s) to Claim(s) and Specification
9) The instant specification is objected to for the following reason(s):
(a) The use of trademark recitations in the instant specification has been noted. For example, see section [0092] for ‘Triton X-100’. All trademark recitations should be CAPITALIZED wherever they appear, or where appropriate, should include a proper symbol indicating use in commerce such as TM, SM, or ® following the term. See M.P.E.P 608.01(v) and Appendix l. Although the use of trademarks is permissible in patent applications, the propriety nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks. It is suggested that Applicants examine the whole specification to make similar corrections to trademark recitations, wherever such recitations appear.
(b) Claim 1 is objected to for including the abbreviated limitations ‘LRP1’ and ‘TSLP’. It is suggested that Applicants recite the full or expanded terminology at first occurrence or in the base claim with the abbreviation retained within parentheses.
Rejection(s) under 35 U.S.C § 112(b) or Pre-AIA , Second Paragraph
10) The following is a quotation of 35 U.S.C § 112(b):
(B) CONCLUSION - The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
11) Claims 1, 8, 10, 11, 13, 23, 26 and 110 are rejected under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which inventor or a joint inventor, or for the pre-AIA the Applicants regard as the invention.
(a) Claim 1 is indefinite for lacking sufficient antecedence in the limitation ‘condition associated with ....’. See last line. For proper antecedence, it is suggested that Applicants replace the above-identified limitation with --the condition associated with .....--.
(b) Claims 1 and 110 are ambiguous and indefinite in the limitation ‘reduces’ because it is a relative term. The term is not specifically defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the claim. What degree or level of reduction is encompassed, or ‘reduces’ compared to what, is unclear.
(c) Claims 8, 10, 11, 13, 23, 26 and 110, which depend directly or indirectly from claim 1, are also rejected as being indefinite due to the indefiniteness identified above in the base claim.
Notice Re Prior Art Available under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C § 102 and § 103 (or as subject to pre-AIA 35 U.S.C § 102 and § 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection would be the same under either status.
Rejection(s) under 35 U.S.C § 102
12) The following is a quotation of the appropriate paragraphs of 35 U.S.C § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
13) Claims 1, 8, 10, 11 and 110 are rejected under 35 U.S.C § 102(a)(1) and 35 U.S.C § 102(a)(2) as being anticipated by WO 2017/040287 (Applicants’ IDS) (WO ‘287).
WO ‘287 disclosed a method of treating a disease associate with a cytokine storm such as acute myocardial infarction or AMI (i.e., LRP1-associated condition or disease) or reducing acute myocardial infarction (AMI) and a method of reducing the infarct size and inflammatory response in an affected subject or a subject in need thereof, the method comprising administering to a patient a therapeutically effective amount of a pharmaceutical composition comprising an anti-inflammatory SERPIN peptide comprising SEQ ID NO: 57 or SP163M. The administering was oral, topical or parenteral. The administered dose was a single dose and the therapeutically effective amount was a dose of between 0.0001 to 1000 mg/kg. See claims 5(h), 6, 3(h), 4, 1(p) and 2; sections [0013], [0059] to [0061], [0063], [00200] to [00202], [00211], [00287], [00297], and [00205]; Figure 4A, 5A, 6A and 8; line 1 of section [0078]; and Example 1. The function of reducing eosinophilic inflammation is an inherent characteristic intrinsic to the administered SEQ ID NO: 57.
Claims 1, 8, 10, 11 and 110 are anticipated by WO ‘287.
14) Claims 1, 8, 10, 11 and 110 are rejected under 35 U.S.C § 102(a)(1) and 35 U.S.C § 102(a)(2) as being anticipated by Toldo et al. (JACC Basic Transl. Sci. 2(5): 561-574, 2017 - Applicants’ IDS) as evidenced by Wohlford et al. (PLOS ONE 16(5): e0247357, pages 1/1 to 1/11, 06 May 2021).
Toldo et al. taught a method of parenterally administering to mice having myocardial infarction 100 or 10 micrograms in one dose, or three doses of 4 microgram of the SP16 peptide sequence VKFNKPFVFLNIeIEQNTK, i.e., the instantly recited SEQ ID NO: 35. The method conferred cardioprotection to the mice, preserved left ventricular systolic function, and resulted in the reduction in the size of the infarct. See paragraph bridging pages 563 and 564; the paragraph bridging the two columns of page 564; the 1st full paragraph in right column of page 564; last full paragraph in left column of page 564; left column of page 565; last full paragraph in right column of page 565; the amino acid sequence depicted at the top of the Figure set forth on page 566; last full paragraph in left column of pages 567 and 568; page 568; the Figure set forth on page 569; and Figure 7A. That the dose of the SP16 administered in Toldo’s method was 0.1 mg/kg which falls within the dose range recited in instant claim 8 is inherent from the teachings of Toldo et al. in light of what is known in the art. For instance, Wohlford et al. taught the dose of the administered SP16 which reduced the infarct size and preserved the left ventricular systolic function in the method of reference 5 therein, i.e., Toldo et al. JACC Basic Transl. Sci. 2(5): 561-574, 2017, was 0.1 mg/kg. See 6th full sentence of 2nd full paragraph of page 8/11 of Wohlford et al. The function of reducing eosinophilic inflammation is an inherent characteristic intrinsic to the administered SP16.
Claims 1, 8, 10, 11 and 110 are anticipated by Toldo et al.
Double Patenting Rejection(s)
15) The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(1)(1) - 706.02(1)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.aspto.gov/paients/process/fIle/efs/giiidance/eTD-mfo-I.jsp.
16) Claims 1, 8, 10, 11, 26 and 110 are rejected ground of non-statutory obviousness double patenting as being unpatentable over claims 1-12 of US 11020462 B2 (Applicants’ IDS). Although the claims at issue are not identical, they are not patentably distinct from each other. Said claims of the ‘462 patent, drawn to a method of treating acute myocardial infarction (AMI), i.e., a LRP1 or TSLP associated condition, comprising administering orally or subcutaneously the SERPIN peptide VKFNKPFVFL[NIe]IEQNTK (SEQ ID NO: 57), i.e., the instantly recited SEQ ID NO: 35, to a human subject affected with AMI, read on and anticipate instant claims. Furthermore, as in In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008), the parts of the ‘462 patent’s specification that define the administered dose includes 1 mg/kg or 0.5 mg/kg and a single dose; and the route of administration includes topical or oral administration (see the section entitled ‘Dosage’ beginning at lines 24 of column 34; and 3rd full paragraph in column 35) indicating that these doses and the routes of administration are intended to fall within the coverage and/or meaning of the claims. Note that ‘[The specification] may be used to learn the meaning of terms and in interpreting the coverage of a claim’ [Emphasis added]. In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Also per MPEP § 804 (II)(B)(2)(a), the specification can be used as a dictionary to learn the meaning of a term in the patent claim. Reduction in eosinophilic inflammation is an inherent characteristic intrinsic to the administered SEQ ID NO: 57.
17) Claims 1, 8, 10, 11, 13, 23, 26 and 110 are rejected ground of non-statutory obviousness double patenting as being unpatentable over claims 1-6 of US patent 11779630 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Said claims of the ‘630 patent, drawn to a method of treating a human subject suffering from a TSLP-associated disease or condition including atopic dermatitis comprising administering orally, parenterally, topically, intranasally, transdermally or intradermally a single dose of a composition comprising the SERPIN peptide VKFNKPFVFL[NIe]IEQNTK, i.e., SEQ ID NO: 35, a dose being between 0.001 mg/kg and 5 mg/kg, read on and anticipate instant claims. Reduction in eosinophilic inflammation is an inherent characteristic intrinsic to the administered SEQ ID NO: 35.
Conclusion
18) No claims are allowed.
Correspondence
19) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 7.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisor, Gary Nickol, can be reached at (571) 272-0835. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
20) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
August, 2025